Home / 510(k) Clearances / K841211

510(k) K841211

SELECTIVE BROTH by Smith River Biologicals — Product Code JSD

K841211 is an FDA 510(k) premarket notification submitted by Smith River Biologicals for the device "SELECTIVE BROTH". The FDA issued a decision of Substantially Equivalent on April 5, 1984. The device falls under product code JSD (Culture Media, Selective Broth), a Class I device regulated under 21 CFR 866.2360. Smith River Biologicals has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 5, 1984
Date Received
March 12, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Culture Media, Selective Broth
Device Class
Class I
Regulation Number
866.2360
Review Panel
MI
Submission Type

Other clearances by Smith River Biologicals

  • K923892 — SMITH RIVER MICROBIOLOGICAL CULTURE MEDIA (June 21, 1993)
  • K841207 — NON-SELECTIVE & NON-DIFFERENTIAL (April 17, 1984)
  • K841206 — NON-SELECTIVE & DIFFERENTIAL (April 17, 1984)
  • K841204 — MULTIPLE BIOCHEMICAL TEST (April 17, 1984)
  • K841209 — SELECTIVE AND DIFFERENTIAL (April 17, 1984)
  • K841208 — PROPAGATING TRANSPORT (April 5, 1984)
  • K841213 — ANTIMICROBIAL SUSCEPT-CULTURE MEDIA (April 4, 1984)
  • K841205 — NON PROPAGATING TRANSPORT (April 4, 1984)
  • K841212 — SINGLE BIOCHEMICAL TEST (April 4, 1984)
  • K841203 — GENERAL NUTRIENT BROTH (April 4, 1984)

Other clearances for product code JSD

  • K883075 — FASTIDIOUS INOCULUM BROTH (August 15, 1988)
  • K880107 — CAMPY BROTH (March 30, 1988)
  • K873324 — SABOURAUD DEXTROSE (SD) BROTH TUBE, #T3331 (October 2, 1987)
  • K873218 — BRAIN HEART INFUSION BROTH W/6.5% NAC1 - #T3802 (September 23, 1987)
  • K871447 — TODD HEWITT W/CNA (LIM BROTH) (May 13, 1987)
  • K871640 — ALKALINE PEPTONE WATER (May 13, 1987)
  • K870594 — T9802 TSB W/6.5% NACL (March 30, 1987)
  • K853609 — APL TRYPTIC SOY BROTH (September 12, 1985)
  • K844547 — TRYPTIC SOY BROTH W/6.5%SODIUM CHLORIDE (January 16, 1985)
  • K841836 — SELECTIVE CULTURE MED. TRICHOMONAS (May 14, 1984)

FDA data resources